FCF · Instrument, Biopsy, Mechanical, Gastrointestinal
Gastroenterology, Urology · 21 CFR 876.1075 · Class 2
Overview
| Product Code | FCF |
|---|---|
| Device Name | Instrument, Biopsy, Mechanical, Gastrointestinal |
| Regulation | 21 CFR 876.1075 |
| Device Class | Class 2 |
| Review Panel | Gastroenterology, Urology |
| 3rd-Party Reviewable | Yes |
Identification
A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.
Classification Rationale
(1) Class II (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
Recent Cleared Devices (6 of 6)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K070759 | POWERED EZ-IO PEDIATRIC BONE MARROW ASPIRATION SYSTEM | Vidacare Corporation | May 21, 2007 | SESE |
| K062833 | POWERED EZ-IO BONE MARROW ASPIRATION SYSTEM | Vidacare Corporation | Nov 30, 2006 | SESE |
| K984168 | BARRETT'S ESOPHAGEAL CYTOLOGY DEVICE | United States Endoscopy Group, Inc. | Dec 7, 1999 | SESE |
| K915142 | AMCATH DISPOSABLE BIOPSY FORCEPS | Intl. Medical, Inc. | Jan 10, 1992 | SESE |
| K911155 | OVAL CUP BIOPSY FORCEP | Endovations | Aug 7, 1991 | SESE |
| K843477 | PHARMA-PLAST RECTAL TIP | Zimmar Consulting , Ltd. | Dec 5, 1984 | SESE |
Top Applicants
- Vidacare Corporation — 2 clearances
- Zimmar Consulting , Ltd. — 1 clearance
- United States Endoscopy Group, Inc. — 1 clearance
- Intl. Medical, Inc. — 1 clearance
- Endovations — 1 clearance
